(35 days)
Not Found
No
The summary describes a standard immunochemistry assay using rate nephelometry, a well-established analytical technique. There is no mention of AI, ML, or any computational methods beyond standard data processing for quantitative determination.
No.
The device is intended for the quantitative determination of C-reactive protein concentrations, which aids in evaluation of stress, trauma, infection, inflammation, and surgery. This is a diagnostic function, not a therapeutic one.
Yes
The device is described as aiding in the "evaluation of stress, trauma, infection, inflammation, and surgery" by measuring C-reactive protein concentrations, which is a diagnostic purpose.
No
The device description explicitly states it is a "reagent" and is used "in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems," indicating it is a chemical component used with a hardware system, not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of human C-reactive protein concentrations in human serum and plasma samples." This involves testing biological samples in vitro (outside the body).
- Device Description: The description reinforces that it's a "reagent" used in conjunction with a system for determining concentrations in "human serum and plasma samples."
- Clinical Significance: The clinical significance describes how the measurement aids in the "evaluation of stress, trauma, infection, inflammation, and surgery," which are all diagnostic purposes.
- Performance Studies: The performance studies describe experiments like "method comparison, stability, linearity, and imprecision experiments," which are typical evaluations for IVD devices.
- Key Metrics: The key metrics provided (imprecision data) are standard performance characteristics for quantitative IVD assays.
- Predicate Device: The mention of a "Predicate Device" with a K number (K962523 Behring N Latex CRP) is a strong indicator that this device is being compared to another legally marketed IVD device for regulatory purposes.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry System C-reactive protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry.
Product codes
DCK
Device Description
The IMMAGE Immunochemistry System C-Reactive Protein (CRP) reagent, in conjunction with Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE® Immunochemistry System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.
Within-Run Imprecision:
Level 1: Mean = 0.35 mg/dL, S.D. = 0.039 mg/dL, %C.V. = 11.1, N = 80
Level 2: Mean = 4.95 mg/dL, S.D. = 0.129 mg/dL, %C.V. = 2.6, N = 80
Level 3: Mean = 6.69 mg/dL, S.D. = 0.236 mg/dL, %C.V. = 3.5, N = 80
Total Imprecision:
Level 1: Mean = 0.35 mg/dL, S.D. = 0.043 mg/dL, %C.V. = 12.1, N = 80
Level 2: Mean = 4.95 mg/dL, S.D. = 0.149 mg/dL, %C.V. = 3.0, N = 80
Level 3: Mean = 6.69 mg/dL, S.D. = 0.266 mg/dL, %C.V. = 4.0, N = 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
0
JUN 12 1998
BECKMAN
Summary of Safety & Effectiveness IMMAGE® Immunochemistry System C-Reactive Protein (CRP) Reagent
1.0 Submitted By:
Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123
2.0 Date Submitted:
May 7, 1998
3.0 Device Name(s):
- 3.1 Proprietary Names
IMMAGE® Immunochemistry System C-Reactive Protein (CRP) Reagent
3.2 Classification Name
C-Reactive Protein immunological test system (21 CFR § 866.5270)
4.0 Predicate Device(s):
| IMMAGE System
Reagent | Predicate | Manufacturer | Docket
Number |
|------------------------------------------------------|---------------------|----------------------|------------------|
| IMMAGE System
C-Reactive Protein
(CRP) Reagent | Behring N Latex CRP | Behring Diagnostics* | K962523 |
- Behring Diagnostics (Westwood, MA)
5.0 Description:
The IMMAGE Immunochemistry System C-Reactive Protein (CRP) reagent, in conjunction with Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE® Immunochemistry System.
6.0 Intended Use:
The IMMAGE® Immunochemistry System C-Reactive Protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry.
Beckman Instruments, Inc.
1
Comparison to Predicate(s): 7.0
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary. A STATISTIC COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTI
| SIMILARITIES | ||
|---|---|---|
| IMMAGE System | ||
| CRP Reagent | Intended Use | Same as Behring |
| N Latex CRP | ||
| Nephelometric methodology | ||
| Use of Latex particle | ||
| technology | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| CRP Reagent | Form of reagent | the IMMAGE CRP is liquid stable |
| while Behring N Latex CRP | ||
| reagent is lyophilized | ||
| Antibody source | IMMAGE CRP uses goat while | |
| Behring N Latex CRP uses rabbit. | ||
| Stability | IMMAGE CRP is stable for 30 | |
| days once opened, properly stored | ||
| while Behring N Latex CRP | ||
| reagent is stable for one week | ||
| following reconstitution. |
Summary of Performance Data: 8.0
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.
Method Comparison Study Results IMMAGE C-Reactive Protein (CRP) Reagent
|
Taxas
Панаваларускаяния марактеническа чемка Геонин - уческа.
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LELARSHIP WANNER FRANCE PARKERSANTED
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**************************************************** |
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| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 0.35 | 0.039 | 11.1 | 80 |
| Level 2 | 4.95 | 0.129 | 2.6 | 80 |
| Level 3 | 6.69 | 0.236 | 3.5 | 80 |
| Total Imprecision | ||||
| Level 1 | 0.35 | 0.043 | 12.1 | 80 |
| Level 2 | 4.95 | 0.149 | 3.0 | 80 |
| Level 3 | 6.69 | 0.266 | 4.0 | 80 |
Estimated Improvision
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle.
JUN 1 2 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Annette Hellie Senior Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 Brea, California 92822-8000
Re : K981638
IMMAGE® Immunochemistry System C-Reactive Protein Trade Name: (CRP) Reagent
Regulatory Class: II Product Code: DCK Dated: May 7, 1998 Received: May 8, 1998
Dear Ms. Hellie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
3
Paqe 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
page ___ of ]
510(k) Number (if known):
K9816638
Device Name: IMMAGE® Immunochemistry System C-Reactive Protein (CRP) Reagent
Indications for Use:
The IMMAGE Immunochemistry System C-reactive protein (CRP) reagent, in conjunction with Beckman Coulter IMMAGE® Immunochemistry Systems and Calibrator 5 Plus, is intended for use in the quantitative determination of human Creactive protein concentrations in human serum and plasma samples by rate nephelometry.
Clinical Significance:
Measurement of C-reactive protein aids in evaluation of stress, trauma, infection, inflammation, and surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number | K981638 | |
|---|---|---|
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------- |
| Prescription Use | OR | Over-the-Counter Use |
|---|---|---|
| (per 21 CFR 801.109) | Optional Format 1-2-96 |